medical Class II Updated 2024-10-02

Siemens Medical Solutions USA, Inc. recalls ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, RE

Recalled Product

ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software

Hazard / Issue

If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management

Issued by

FDA

Affected States: MS, WA, TX, NJ, GA, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, OR, MA

Lot/Code Info: 11503314, UDI-DI: 04056869251264: 1.0/Software VA10G and prior, 2.0/Software VA20K and prior

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